Efficacy and Safety Trial of ADU-S100 and Pembrolizumab in Head and Neck Cancer

A Phase 2 Efficacy and Safety Trial of ADU-S100 and Pembrolizumab in Adults With Head and Neck Cancer

ADU-CL-20 is an open-label, multicenter Phase 2 clinical trial to evaluate the efficacy and safety of intratumoral ADU-S100 (also referred to as MIW815) administered with pembrolizumab in the first-line setting. The population will consist of adults with PD-L1 positive recurrent or metastatic HNSCC.

Inclusion Criteria:

• Histological or cytological confirmation of recurrent or metastatic HNSCC
• Measurable disease as defined by RECIST v1.1
• PD-L1 positive

Exclusion Criteria:

• Diagnosis of recurrent or metastatic carcinoma of the nasopharynx, squamous cell carcinoma of unknown primary histology; or salivary gland or non-squamous histologies (e.g. mucosal melanoma)
• Disease amenable to local therapy with curative intent (surgery or radiation therapy with or without chemotherapy)
• Prior systemic anti-cancer therapy (use of chemotherapeutic agents, targeted small molecules, immunotherapy, or monoclonal antibodies) for the treatment of recurrent or metastatic HNSCC